SWC for Treatment of Superficial Partial-Thickness Burns

NCT05877638 | Terminated FDA Device

• 1 other identifier: SWC
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the safety and effectiveness of SynePure™ Wound Cleanser when used in combination with Catasyn™ Advanced Technology Hydrogel for the treatment of superficial partial-thickness burn wounds.

Conditions

Burn Wounds

Outcome Measures

Primary Outcomes (1)

• Percentage of healing wound progress across study window

  Healing is defined as 90% re-epithelialization (skin and mucous membrane replacement) of the wounded area

  Up to 21days

Secondary Outcomes (1)

• Number of new infection rates

  Up to 21days

Other Outcomes (1)

• Number of complications other than infection

  Up to 21days

Study Arms (2)

SynePure with Catasyn

EXPERIMENTAL

SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel

Device: SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel

Silvadene

ACTIVE COMPARATOR

Routine care wound rinse and Silvadene cream

Drug: SILVADENE Cream 1% (silver sulfadiazine)

Interventions

SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel DEVICE

(FDA) 510(k) cleared wound care medical devices formulated with a novel biocompatible chitosan derivative, poly (acetyl, arginyl) glucosamine. SynePure is optimized for the cleansing and debridement of wounds and thermal injuries, and Catasyn serves as a protective gel dressing.

SynePure with Catasyn

SILVADENE Cream 1% (silver sulfadiazine) DRUG

SILVADENE Cream 1% (silver sulfadiazine) is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second- and third-degree burns.

Silvadene

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients otherwise in good general physical and mental health, as per the investigator's clinical judgment.

You may not qualify if:

• Inability to provide informed consent
• Radiation, chemical or electrical burn injury
• Patients with burns primarily located to the face, genitals, or span across joints
• Patients whose burn injury was ≥ 8 days prior to entry into the Burn Center/ Clinic.
• Patients with uncontrolled cerebrovascular disease, cardiovascular disease, concurrent endocrine, hepatic or renal disease, or other severe conditions for whom, in the investigators' discretion would render study participation unsafe
• Patients with documented or self-reported shellfish allergies
• Current pregnancy
• Patients with concurrent burn related injuries or inhalation injury that would put the patient at increased risk, per physician discretion
• Any condition to which in the investigator's discretion would render study enrollment a safety concern for the patient.

Sponsors & Collaborators

• Synedgen, Inc.: lead
• Louisiana State University Health Sciences Center in New Orleans: collaborator

Study Sites (1)

Louisiana State University Health Science Center at New Orleans

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Conditions

Burns

Interventions

Silver Sulfadiazine

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Sulfadiazine; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Shenda Baker, PhD

  Synedgen, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: May 26, 2023
• Study Start: March 27, 2023
• Primary Completion: June 20, 2024
• Study Completion: June 20, 2024
• Last Updated: December 3, 2024

Record last verified: 2024-05

Locations

US (1)